Clinical Study Phase III, Randomized, Double-blind, Prospective and Comparative to Evaluate the Efficacy and Tolerability of Using APETIVITON BC Compared to Petivit BC in Appetite Stimulate.
试验速览
- 阶段
- 3 期
- 入组人数
- 150
- 主要终点
- Evaluate the effectiveness of apetiviton BC compared to Petivit BC in appetite stimulation in children, adults and seniors.
研究概览
简要总结
Clinical study phase III, randomized, double-blind, prospective, comparative non-inferiority to evaluate the efficacy and tolerability of using APETIVITON BC compared to Petivit BC in appetite stimulate in children, adults and elderly.
详细描述
Clinical trial phase III, randomized, double-blind, prospective, comparative non-inferiority to evaluate the efficacy and tolerability of using APETIVITON BC compared to Petivit BC stimulation of appetite in children, adults and elderly. A total of 150 patients, distributed as follows:
25 patients treated children Apetiviton BC,25 patients treated children Petivit BC, (2-6 years).
25 adult patients treated with Apetiviton BC,25 adult patients treated with Petivit BC, (18-50 years.
25 elderly patients treated with Apetiviton BC,25 elderly patients treated with Petivit BC. (60-80 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 2 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For both groups:
- •Patients who have inappetence;
- •Patients able to understand and maintain adherence to protocol;
- •Wash-out 20 days after ingestion of prior similar drug;
- •Patients able to understand the correct use of medication;
- •Patients who consent to participate in the study by signing the inform consent;
- •Patients of any ethnic group male and female, aged between 2 and 6 years;
- •Patients of any ethnic group male and female, aged between 18 and 50 years;
- •Female patients in childbearing age, sexually active, make pregnancy test result should be negative and, furthermore, should be using contraceptive methods such as contraception, condom, IUD and diaphragm.
- •Patients of any ethnic group male and female, aged between 60 and 80 years.
- •Female patients in childbearing age, sexually active, make pregnancy test result should be negative and, furthermore, should be using contraceptive methods such as contraception, condom, IUD and diaphragm.
排除标准
- •For both groups:
- •Patients with glaucoma open or closure angle;
- •Patients with predisposition to urinary retention;
- •Patients with stenous peptic ulcer or pylorus-duodenal obstruction;
- •Debilitated patients or in acute attack of asthma;
- •Alcoholic;
- •Patients who have loss of appetite caused by any serious disease;
- •Patients who make use of any drugs central nervous system depressants;
- •Patients who make use of medicines monoaminooxidase inhibitors, tricyclic antidepressants, phenothiazines, probenecid, levodopa, phenytoin, phenobarbital, chloramphenicol, cyclophosphamide, cyclosporine, chlorambucil, corticotropin, mercaptopurine, isoniazid, penicillin, estrogens, contraceptives, haloperidol, ipatrópico, barbiturates, primidone, salicylates;
- •Patients with known hypersensitivity to any components of the formula;
- •Patient who is participating in another clinical study;
- •No able to adhere to protocol;
- •Patients who are pregnant or breastfeeding;
- •Any condition that in the opinion of the investigator can impossible to include the patient's adherence to the protocol.
研究组 & 干预措施
Petivit BC
干预措施: Apetiviton BC (Drug)
Apetiviton BC
干预措施: Apetiviton BC (Drug)
结局指标
主要结局
Evaluate the effectiveness of apetiviton BC compared to Petivit BC in appetite stimulation in children, adults and seniors.
时间窗: 30 days
次要结局
- Evaluate the tolerability of apetiviton BC compared to Petivit BC the stimulation of appetite in children, adults and seniors(30 days)